1. Field of Inventions
The present inventions relate generally to structures for positioning diagnostic and therapeutic elements within the body and, more particularly, to devices which are particularly well suited for the treatment of cardiac conditions.
2. Description of the Related Art
There are many instances where diagnostic and therapeutic elements must be inserted into the body. One instance involves the treatment of cardiac conditions such as atrial fibrillation and atrial flutter which lead to an unpleasant, irregular heart beat, called arrhythmia.
Normal sinus rhythm of the heart begins with the sinoatrial node (or xe2x80x9cSA nodexe2x80x9d) generating an electrical impulse. The impulse usually propagates uniformly across the right and left atria and the atrial septum to the atrioventricular node (or xe2x80x9cAV nodexe2x80x9d). This propagation causes the atria to contract in an organized way to transport blood from the atria to the ventricles, and to provide timed stimulation of the ventricles. The AV node regulates the propagation delay to the atrioventricular bundle (or xe2x80x9cHISxe2x80x9d bundle). This coordination of the electrical activity of the heart causes atrial systole during ventricular diastole. This, in turn, improves the mechanical function of the heart. Atrial fibrillation occurs when anatomical obstacles in the heart disrupt the normally uniform propagation of electrical impulses in the atria. These anatomical obstacles (called xe2x80x9cconduction blocksxe2x80x9d) can cause the electrical impulse to degenerate into several circular wavelets that circulate about the obstacles. These wavelets, called xe2x80x9creentry circuits,xe2x80x9d disrupt the normally uniform activation of the left and right atria.
Because of a loss of atrioventricular synchrony, the people who suffer from atrial fibrillation and flutter also suffer the consequences of impaired hemodynamics and loss of cardiac efficiency. They are also at greater risk of stroke and other thromboembolic complications because of loss of effective contraction and atrial stasis.
Although pharmacological treatment is available for atrial fibrillation and flutter, the treatment is far from perfect. For example, certain antiarrhythmic drugs, like quinidine and procainamide, can reduce both the incidence and the duration of atrial fibrillation episodes. Yet, these drugs often fail to maintain sinus rhythm in the patient. Cardioactive drugs, like digitalis, Beta blockers, and calcium channel blockers, can also be given to control the ventricular response. However, many people are intolerant to such drugs. Anticoagulant therapy also combats thromboembolic complications, but does not eliminate them. Unfortunately, pharmacological remedies often do not remedy the subjective symptoms associated with an irregular heartbeat. They also do not restore cardiac hemodynamics to normal and remove the risk of thromboembolism.
Many believe that the only way to really treat all three detrimental results of atrial fibrillation and flutter is to actively interrupt all of the potential pathways for atrial reentry circuits.
One surgical method of treating atrial fibrillation by interrupting pathways for reentry circuits is the so-called xe2x80x9cmaze procedurexe2x80x9d which relies on a prescribed pattern of incisions to anatomically create a convoluted path, or maze, for electrical propagation within the left and right atria. The incisions direct the electrical impulse from the SA node along a specified route through all regions of both atria, causing uniform contraction required for normal atrial transport function. The incisions finally direct the impulse to the AV node to activate the ventricles, restoring normal atrioventricular synchrony. The incisions are also carefully placed to interrupt the conduction routes of the most common reentry circuits. The maze procedure has been found very effective in curing atrial fibrillation. However, the maze procedure is technically difficult to do. It also requires open heart surgery and is very expensive. Thus, despite its considerable clinical success, only a few maze procedures are done each year.
Maze-like procedures have also been developed utilizing catheters which can form lesions on the endocardium to effectively create a maze for electrical conduction in a predetermined path. Exemplary catheters are disclosed in commonly assigned U.S. Pat. No. 5,582,609. Typically, the lesions are formed by ablating tissue with an electrode carried by the catheter. Electromagnetic radio frequency (xe2x80x9cRFxe2x80x9d) energy applied by the electrode heats, and eventually kills (i.e. xe2x80x9cablatesxe2x80x9d), the tissue to form a lesion. During the ablation of soft tissue (i.e. tissue other than blood, bone and connective tissue), tissue coagulation occurs and it is the coagulation that kills the tissue. Thus, references to the ablation of soft tissue are necessarily references to soft tissue coagulation. xe2x80x9cTissue coagulationxe2x80x9d is the process of cross-linking proteins in tissue to cause the tissue to jell. In soft tissue, it is the fluid within the tissue cell membranes that jells to kill the cells, thereby killing the tissue.
Catheters used to create lesions (the lesions being 3 to 15 cm in length) typically include a relatively long and relatively flexible body portion that has one or more electrodes at or near its distal end. The portion of the catheter body portion that is inserted into the patient is typically from 23 to 55 inches in length and there may be another 8 to 15 inches, including a handle, outside the patient. The proximal end of the catheter body is connected to the handle which includes steering controls. The length and flexibility of the catheter body allow the catheter to be inserted into a main vein or artery (typically the femoral artery), directed into the interior of the heart, and then manipulated such that the electrode contacts the tissue that is to be ablated. Fluoroscopic imaging is used to provide the physician with a visual indication of the location of the catheter.
Catheter-based soft tissue coagulation has proven to be a significant advance in the medical arts generally and in the treatment of cardiac conditions in particular. Nevertheless, the inventors herein have determined that catheter-based procedures are not appropriate in every situation. It can be difficult to precisely position the distal portion of conventional catheters. It can also be difficult to achieve adequate tissue contact.
One particular lesion that has proven to be difficult to form with conventional catheters is the circumferential lesion that is used to isolate a pulmonary vein and cure ectopic atrial fibrillation. Lesions that isolate the pulmonary vein may be formed within the pulmonary vein itself or in the tissue surrounding the pulmonary vein. Lesions may be created such that a single circumferential lesion isolates a single pulmonary vein or such that a single circumferential lesion isolates more than one pulmonary vein. The circumferential lesions are formed by dragging a tip electrode around the pulmonary vein or by creating a group of interconnected curvilinear lesions one-by-one around the pulmonary vein. Such techniques have proven to be less than effective because they are slow and gaps of conductive tissue can remain after the procedure.
Endocardial lesions have also been formed as a secondary procedure during a primary open heart surgical procedure such as mitral valve replacement, aortic valve replacement, and coronary artery bypass grafting. A surgical soft tissue coagulation probe is used to form the endocardial lesions after the heart has been opened, either before or after the valve replacement. This technique has proven to be quite useful, especially for forming lesions that isolate pulmonary veins. It does, however, increase the amount of time the patient is on pulmonary bypass, which can be undesirable. The inventors herein have, therefore, determined that a need exists for surgical methods and apparatus that can be used to create lesions on bodily structures and, in the context of the treatment of atrial fibrillation, to create therapeutic lesions that do not require the patient to be on pulmonary bypass.
Another issue associated with lesion formation is tissue cooling. There are many instances where it is desirable to create lesions that are wider and deeper than those which can be created with conventional electrode structures. One method of increasing lesion size is to cool the tissue during the lesion formation process. Removal of heat from the tissue that is the closest to the coagulation electrodes shifts the hottest iso-thermal region deeper into the tissue, thereby enabling higher power to be delivered without causing char or excessive surface desiccation to occur. Higher power, in turn, results in a larger volume of tissue being heated to a temperature sufficient to coagulate tissue (above 50xc2x0 C.) and, therefore, a wider and deeper lesion.
Although conventional tissue cooling methods have proven to be an advance in the art, the inventors herein have determined that conventional tissue cooling methods are susceptible to improvement and, in particular, that a need exists for tissue cooling apparatus that is well suited for use in the formation of elongate lesions.
Accordingly, the general object of the present inventions is to provide methods and apparatus that avoid, for practical purposes, the aforementioned problems. In particular, one object of the present inventions is to provide surgical methods and apparatus that can be used to create lesions in a more efficient manner than conventional apparatus. Another object of the present inventions is to provide surgical methods and apparatus that can be used to create lesions while the heart is beating. Still another object of the invention is to provide tissue cooling apparatus that may be used during the formation of elongate lesions which is superior to conventional cooling apparatus and suitable for epicardial and endocardial applications.
In order to accomplish some of these and other objectives, a device in accordance with a present invention includes a shaft, at least one energy transmission device and a tissue cooling apparatus. Such a device provides a number of advantages over the conventional lesion creation devices. The tissue cooling capability, for example, allows the present device to form wider and deeper lesions than the conventional surgical devices.
One particular implementation of the inventions is a surgical device with a relatively short shaft. Such surgical devices are especially useful in epicardial applications requiring continuous transmural lesions. In the context of the treatment of atrial fibrillation, for example, continuous transmural lesions may be created around one or more pulmonary veins while the heart is beating. Other epicardial lesions may also be created. The heart need not be opened and pulmonary bypass is not required. As such, the present devices advantageously allow curative lesions to be formed without the difficulties associated with catheter-based procedures or the time on pulmonary bypass required by conventional surgical procedures.
In another implementation, the tissue cooling apparatus includes an outer member positioned about the energy transmission device such that a fluid transmission space is defined therebetween and a source that supplies conductive fluid to outer member inlet such that the conductive fluid flows from the inlet to the outlet while energy is being transmitted from the energy transmission device. During a lesion creation procedure, heat will be transferred from the tissue to the flowing conductive fluid thereby enabling the formation of wider and deeper lesions. In addition, because fresh fluid continues to be supplied to the inlet during the procedure, the amount of heat removed from the tissue is greater than it would be if the fluid remained stagnant within the space.
The above described and many other features and attendant advantages of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.